Product Dossier
NICORETTE
Product Dossier for NICORETTE (nicotine, Johnson & Johnson). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Johnson & Johnson
- Active ingredient: nicotine
- Therapeutic area: Psychiatry
- Same area: REXULTI
- Same area: INVEGA
What it is
Nicorette is a nicotine replacement therapy product sponsored by Johnson & Johnson. Nicorette is available in multiple formulations, including chewing gum (2 mg and 4 mg strengths in various flavours), transdermal patches (10 mg, 15 mg and 25 mg per 16 hour), sublingual tablets (2 mg), buccal inhalation cartridges (15 mg), lozenges (2 mg and 4 mg), and metered dose aerosol spray (1 mg per spray).
Approved indications
— Nicotine dependence.
PBS listing
Nicorette transdermal patch 39.4 mg is listed on the PBS with restricted benefit status. The ex-manufacturer price is A$35.23.
Regulatory history
Nicorette chewing gum formulations (2 mg and 4 mg classic flavour) were first registered on the ARTG on 13 August 1991. The buccal inhalation cartridge (15 mg) and sublingual tablet (2 mg) formulations were registered on 27 November 2001. The transdermal patch formulations (10 mg, 15 mg and 25 mg per 16 hour) were first registered on 18 June 2009. The metered dose aerosol spray (1 mg per spray) was registered on 3 May 2012. Lozenge formulations were registered from August 2011 onwards. In March 2018, the PBAC recommended Nicorette for PBS listing for nicotine dependence as a restricted benefit for monotherapies.